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This sunlamp product is intended exclusively for aesthetic tanning of the human skin, for one person at a time, at the age of 18 or above.

The primary technical components of sunlamp products are artificial sources of UV radiation as well as a mechanical structure with a defined active surface.

UV lamps emit different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly. The UV-B radiation is primarily responsible for more long-term tanning results. Traditional UV light with the addition of (beauty) red light results in a natural looking tan. Optimal tanning results are achieved due to the synergistic combination of light spectra.

The provided text is a 510(k) summary for sunlamp products (Ergoline Inspiration 550 Hybrid Technology and Ergoline Planet Fitness 42/4 Hybrid Light Technology). It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific performance criteria through a clinical study or complex AI validation.

Therefore, many of the requested details, such as those related to AI algorithm performance (e.g., sample size for test/training sets, expert ground truth, MRMC study, standalone performance, validation of ground truth), are not present in this document because they are not applicable to the type of device and regulatory submission described.

The "performance testing" mentioned in the document refers to compliance with established electrical, mechanical, and safety standards for sunlamp products, not an AI-driven diagnostic or treatment device.

Here's an analysis based on the available information and an explanation of why other requested information is not present:

Device Description: Sunlamp products (Ergoline Inspiration 550 Hybrid Technology, Ergoline Planet Fitness 42/4 Hybrid Light Technology, and their variants).

Intended Use: Exclusively for aesthetic tanning of human skin, for one person at a time, at the age of 18 or above.

Regulatory Class: Class II

Predicate Device: Ergoline Inspiration 600 Dynamic Performance (K151400)

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" for this type of device, as demonstrated in a 510(k), are primarily related to meeting established safety and performance standards for sunlamp products and demonstrating substantial equivalence to a predicate device. There aren't "performance metrics" in the typical sense of accuracy, sensitivity, or specificity as one would see for a diagnostic AI.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. This document describes a submission for a sunlamp and does not involve AI or a complex test set of patient data. The "testing" refers to lab-based compliance testing of the physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. No patient data test set or ground truth establishment by experts for performance evaluation (e.g., diagnostic accuracy) is described.

4. Adjudication method for the test set:

• Not applicable / Not provided. No test set requiring expert adjudication for AI performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. This is a sunlamp product, not an AI-assisted diagnostic device. MRMC studies are not relevant here.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This relates to an AI algorithm, which is not part of this device or submission type.

7. The type of ground truth used:

• Not applicable. No ground truth in the context of diagnostic accuracy is relevant. The "ground truth" for this device would be its adherence to specified physical and electrical parameters and safety standards, as verified through laboratory testing against those standards.

8. The sample size for the training set:

• Not applicable / Not provided. No AI training set is mentioned as part of this device submission.

9. How the ground truth for the training set was established:

• Not applicable / Not provided. No AI training set.

Summary of the Study (as described in the document):

The "study" presented in this 510(k) summary is not a clinical study in the traditional sense, nor is it an AI performance validation study. Instead, it is a design verification and validation process to demonstrate that the new sunlamp devices are substantially equivalent to a previously cleared predicate device and that they comply with applicable U.S. and international safety and performance standards.

The core of the "proof" the device meets acceptance criteria lies in:

• Comparison to Predicate Device: Showing that the proposed devices have identical intended use and similar technological characteristics, with any differences not raising new questions of safety or effectiveness. Key differences (e.g., number of lamps, wattage) are addressed by stating that irradiance characteristics are comparable and safety has been confirmed by corresponding tests.
• Compliance with Recognized Standards: Stating that the devices have been tested and comply with:
  • U.S. Performance Standard 21 CFR 1040.20 (Sunlamp Products)
  • ISO 10993-series (Biocompatibility)
  • IEC 60601-1 (Electrical and Mechanical Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)

The document concludes that the proposed devices are substantially equivalent to the predicate, do not introduce new indications or hazards, and fulfill all Special Controls.

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The Inspiration® 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intrahospital transport.

This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O.

The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support.

The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

The Inspiration™ 71 / 51 Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System (K072950), with the following additions:

• . a GUI change to deliver a GUI similar to that of the eVolution ventilator.
• Additional monitored and trended parameters. .
• . Additional waveforms and loops.
• Additional medium and high priority alarms. .
• . Additional patient setup and default setting criteria.
• . : Integration of SNMP fields for settings, monitored and trended data.
• . Integration of Volumetric and Sidestream Capnography capability (7i model only) The capnography addition will require specific adaptors and sensors to allow use of this feature.
• Integration of various maneuvers

The eVent Medical Ltd. Inspiration 5i/7i Ventilator System is a continuous ventilator. The provided text outlines the device's characteristics and its substantial equivalence to previously cleared predicate devices, but it does not contain typical acceptance criteria and study data as one might expect for an AI/ML powered medical device. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technical characteristics and compliance with established performance standards for ventilators.

Here's a breakdown based on the provided text, aligning with the requested information to the best extent possible given the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a ventilator), "acceptance criteria" are generally tied to meeting established performance standards for medical electrical equipment and critical care ventilators, rather than statistical performance metrics like sensitivity/specificity for an AI model.
The device demonstrates performance by adhering to the following standards:

The document also provides a detailed comparison to predicate devices, showing that the Inspiration 5i/7i shares similar specifications for:

• Description: Functionally identical, with added features (GUI, monitored parameters, waveforms, alarms, setup criteria, SNMP, Capnography, maneuvers).
• Indications for Use: Expanded patient weight and tidal volume ranges (0.3kg-200kg, 5ml-2000ml) compared to the predicate's general "infant through adult" but remains within the same scope.
• Patient Types: Adult, Pediatric, Infant.
• Ventilation Modes (Volume, Pressure, VTV, Apnea backup): All listed modes are identical to the predicate.
• Settings/Controls: Similar primary and advanced settings.
• Monitoring: Includes expanded monitoring parameters compared to the predicate. Integration of Volumetric and Sidestream Capnography capability (7i model only) is a new feature, for which the predicate Hamilton G-5 Ventilator also monitors Capnography parameters.
• Electrical, Battery, Physical, and Environmental Specifications: All are identical or substantially similar to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set in the context of validating an AI/ML model with a specific sample size. The "performance" assessment is based on compliance with established engineering and medical device standards for ventilators, which typically involve testing the physical device against specified operational parameters, safety limits, and durability. Such testing would involve:

• Test Setup: Specialized test lungs, flow meters, pressure sensors, gas analyzers, and other equipment designed to simulate various patient conditions and measure ventilator performance.
• Data Provenance: The testing would be conducted in a controlled laboratory environment by the manufacturer (eVent Medical, Ltd.). The data generated would be from these laboratory tests rather than patient-derived data from specific countries or being retrospective/prospective in nature.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this submission. Ground truth, in the context of AI/ML, refers to expert-labeled data used to train or evaluate models. For a ventilator, the "ground truth" for performance is defined by the technical specifications outlined in the referenced standards (e.g., how accurately a set tidal volume is delivered, or how precisely a pressure control algorithm maintains a target pressure). Performance is measured by calibrated instruments, not by expert human assessment of outputs that require subjective interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Since there is no expert labeling or subjective interpretation of results, no adjudication among experts is required. The device's performance is objectively measured against quantitative standards.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not applicable here. This type of study is relevant for diagnostic or interpretive AI systems where human readers (e.g., radiologists) rely on the AI's output. The Inspiration 5i/7i Ventilator System is a life-support device that directly delivers therapy, not an AI-powered diagnostic or interpretive tool that assists human decision-making in the same way.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable in the AI/ML sense. The ventilator itself operates as a "standalone" system in delivering ventilation based on its internal algorithms and controls, but this is not analogous to the standalone performance of a diagnostic AI algorithm. The device's performance stands alone in its ability to ventilate according to user settings and clinical needs, guided by its software and hardware. The evaluation of its "standalone" performance is covered by the compliance testing to the referenced standards.

7. The Type of Ground Truth Used

The "ground truth" for this device is the technical specifications and performance requirements defined by recognized medical device standards (e.g., IEC 60601-1, IEC 60601-2-12, ASTM F1100-90). The device is tested to ensure it operates within the defined tolerances and safety limits specified by these standards. This is a form of engineering or objective performance ground truth, derived from established industry requirements, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The Inspiration 5i/7i Ventilator System, as described in the submission, is a traditional medical device with software control, not an AI/ML device that undergoes a "training" phase with a large dataset. Its development involves traditional software engineering, control system design, and rigorous testing against specifications.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. As it is not an AI/ML device, there is no "training set" in the context of machine learning, and therefore no ground truth established for such a set. The design and validation relied on established engineering principles, safety standards, and performance test protocols for ventilators.

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The MAMMOMAT Inspiration PRIME system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals.

Mammographic images can be interpreted by either hard copy film or soft copy workstation.

Mammomat Inspiration PRIME is a floor-mounted mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.

The Mammomat Inspiration PRIME provides optional gridless acquisition and progressive reconstruction. During progressive reconstruction a unique algorithm replicates the function of the grid. The grid slides back and no longer absorbs primary radiation, therefore less radiation dose is needed. The Mammomat Inspiration PRIME in gridless acquisition mode reduces radiation dose up to 30 percent.

The system consists of an examination stand with integrated, microprocessorcontrolled, high-frequency generator as well as a radiation shield with an optional height-adjustable control desk in which the Acquisition Workstation (AWS) can be integrated. A swivel arm contains the X-ray tube on the top end and the object table with the detector on the bottom end.

The Siemens Mammomat Inspiration PRIME is a mammography system that introduces an optional gridless acquisition and progressive reconstruction algorithm designed to reduce radiation dose while maintaining image quality.

1. A table of acceptance criteria and the reported device performance

The provided text does not contain explicit acceptance criteria in a table format nor specific numerical performance metrics (e.g., sensitivity, specificity, AUC) for the device's diagnostic performance. Instead, it focuses on demonstrating that the new gridless acquisition mode with progressive reconstruction achieves dose reduction with equivalent image quality compared to the predicate device. The primary performance claim is dose reduction.

Key Claim: The modified Mammomat Inspiration Prime can lower dose up to 30 percent compared to the predicate (P030010/S006) with equivalent image quality.

Device Performance (as reported):

• Dose Reduction: Up to 30% reduction in radiation dose in gridless acquisition mode.
• Image Quality: Equivalent image quality to the predicate device, as evaluated with phantom testing and clinical image review.

2. Sample size used for the test set and the data provenance

The document explicitly mentions "clinical testing to quantify the potential of dose savings" (Section 10) and "clinical image review" (Section 8). However, it does not specify the sample size for the test set used in the clinical image review or the dose savings quantification. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document states that "clinical image review" was conducted (Section 8), implying expert evaluation. However, it does not specify the number of experts involved or their qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document mentions "clinical image review" but does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The submission describes a mammography system and its dose reduction technology, not an AI-based diagnostic tool intended to assist human readers. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers was not conducted or reported. The study focused on validating the image quality of the new gridless acquisition mode against a predicate device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device in question, Mammomat Inspiration PRIME, is a mammography system that produces images. The "new algorithm for progressive image reconstruction" is an integral part of the image generation process, replacing the physical scatter radiation grid. Its performance in terms of image quality and dose reduction is inherently tied to the system itself.

While the algorithm functions independently in reconstructing the image, the evaluation of "equivalent image quality" (Section 8) implies human interpretation of those images. Therefore, a standalone algorithm-only diagnostic performance (without human in the loop for interpretation) was not the focus of this submission, as the device's output (images) is still intended for human review. The claim is about the quality of the image produced by the algorithm, not the algorithm's diagnostic capabilities.

7. The type of ground truth used

For the clinical image review, "equivalent image quality" was assessed. This likely implies a consensus-based expert review of the diagnostic quality and clarity of the images produced by the new system compared to those from the predicate device. The document also mentions "phantom testing" (Section 8), which uses objective, known ground truths provided by a phantom. However, for the clinical aspect, no specific external ground truth (like pathology or outcome data) is explicitly mentioned; rather, it appears to be a comparative assessment of image quality by experts.

8. The sample size for the training set

The document does not mention any "training set" in the context of an AI/machine learning algorithm for diagnostic purposes. The "progressive image reconstruction" is described as a "unique algorithm" (Section 5) that replicates the function of a grid. While such algorithms might involve some form of internal parameter optimization, the submission does not detail its development or refer to a distinct training set in the conventional sense of machine learning for diagnostic tasks.

9. How the ground truth for the training set was established

As no training set is discussed or implied for an AI diagnostic algorithm, the question of how its ground truth was established is not applicable based on the provided text. The algorithm's function is to reconstruct images by identifying and correcting for scatter, not to make a diagnosis.

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The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under supervision of medical professionals.

Mammographic images can be interpreted by either hardcopy film or softcopy workstation.

Mammomat Inspiration is a floor-mounted mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.

The system consists of an examination stand with integrated. microprocessor-controlled, high-frequency generator as well as a radiation shield with an optional height-adjustable control desk in which the Acquisition Workstation (AWS) can be integrated. A swivel arm contains the X-ray tube on the top end and the object table with the detector on the bottom end.

The provided text is a 510(k) summary for the Siemens Mammomat Inspiration, a mammography system. This submission is for an updated version (VB30) compared to a predicate device (VB10). The document primarily focuses on demonstrating substantial equivalence to the predicate device, emphasizing that the core imaging components and algorithms remain unchanged.

Based on the information provided, here's an analysis of the requested points:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or report specific performance metrics for the Mammomat Inspiration VB30 in a format that would typically be used for a new medical device claiming improved diagnostic accuracy or a new clinical capability.

Instead, the submission focuses on demonstrating substantial equivalence to the predicate device (Mammomat Inspiration VB10). The key "performance" reported is that the imaging properties (TFT with pixel size and number and image processing algorithms) have not been modified and are identical to the predicate device. The new features ("Automatic Quality Control" and workflow improvements) are presented as optional and not impacting the fundamental image acquisition or processing for diagnostic interpretation.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not mention any test set, sample size, or data provenance related to a clinical study for the VB30 version to prove its diagnostic performance. The submission relies on the established performance of the predicate device (VB10) and the fact that the core imaging path has not changed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Not applicable. No test set or related ground truth establishment is described for the VB30 in this submission.

4. Adjudication Method for the Test Set:

Not applicable. No test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe a MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The focus is on hardware and software equivalence for image generation and display, not an AI diagnostic aid.

6. Standalone Performance Study:

No. The document does not describe a standalone performance study of an algorithm without human-in-the-loop. The Mammomat Inspiration is an imaging system, not a diagnostic algorithm in this context.

7. Type of Ground Truth Used:

Not applicable. No clinical study involving ground truth for diagnostic performance is described for the VB30. The "ground truth" for this submission appears to be the functional and technical equivalence to the previously approved predicate device.

8. Sample Size for the Training Set:

Not applicable. The document does not describe any machine learning or AI models requiring a training set in the context of diagnostic performance. The "Automatic Quality Control" feature is mentioned, but its development method (e.g., if it uses machine learning and a training set) is not detailed.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As no training set is described for diagnostic purposes, the establishment of its ground truth is not relevant here.

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The Inspiration ® Ventilator is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration Ventilator System provides continuous ventilation to infant, pediatric and adult patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration Ventilator System, with the addition of the capability to deliver a Heliox gas mixture.

This modification is implemented on the Inspiration Ventilator through additional functionality in hardware and software. The existing modalities, pneumatic design, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration Ventilator device.

The provided text does not contain detailed information regarding specific acceptance criteria applied to the Inspiration® Ventilator System regarding its performance with Heliox, nor does it describe a study that explicitly proves the device meets such criteria with detailed performance metrics.

However, based on the available information, we can infer the primary "acceptance criterion" being evaluated is substantial equivalence to existing devices, particularly concerning the addition of Heliox gas mixture delivery. The text focuses on demonstrating that the device operates safely and effectively with Heliox, similar to its operation with air and 100% O2, and does not introduce new safety or effectiveness concerns.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria for Heliox performance are not given, we will infer them from the safety and effectiveness claims.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "eVent Medical's bench studies of the Inspiration with high percentages of Helium." However, no specific sample size for a test set (e.g., number of test scenarios, ventilator units tested, or duration of tests) is provided.

The data provenance for the bench studies is internal to eVent Medical ("eVent Medical's bench studies"). It is implied to be prospective testing conducted by the manufacturer for this submission. The document also refers to a "review of the clinical literature on the operation of the Inspiration with Heliox," but this appears to be a separate supporting review rather than a primary study for this specific device modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The text refers to "eVent Medical's bench studies," implying internal testing, but does not detail the personnel or expert involvement in establishing ground truth for these tests.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the context of "bench studies," it's likely internal verification processes were used, but no specific adjudication method (like 2+1/3+1 expert review) is mentioned, as this is typically more relevant for clinical image interpretation or diagnostic device studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect Size

No, an MRMC comparative effectiveness study was not done or at least not described in this document. This type of study is more common for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a continuous ventilator system and its ability to deliver Heliox.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The testing mentioned, "eVent Medical's bench studies," appears to be standalone testing of the device's performance characteristics (e.g., FIO2 accuracy, ability to deliver Heliox without anoxic mixtures). There is no mention of "human-in-the-loop" performance testing for this specific modification, although the overall device is used with human operation.

7. The Type of Ground Truth Used

For the "bench studies," the ground truth would be based on instrumentation and reference measurements of FIO2, gas mixture composition, and potentially other ventilator parameters, established through validated laboratory methods. For the claim that "Heliox poses no increased health risk," the ground truth is derived from a review of clinical literature.

8. The Sample Size for the Training Set

The document describes software modifications and bench studies for a ventilator, not a machine learning or AI-based diagnostic device that typically requires a "training set" in the context of model development. Therefore, the concept of a "training set sample size" as commonly understood in AI/ML is not applicable here and is not provided.

9. How the Ground Truth for the Training Set Was Established

As explained above, there is no training set in the AI/ML sense described here. The "ground truth" for the device's overall design and software development would be established through engineering specifications, regulatory guidelines, and internal validation processes.

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The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of the capability to set tidal volumes in volume targeted modes down to 5 ml, while 10 ml is the lower limit on the cleared device. This modification is implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface mechanism have remained unchanged from the cleared Inspiration™ ventilator device.

The provided text describes a 510(k) premarket notification for a medical device, the Inspiration™ Ventilator System. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria or a study proving those criteria were met for this particular submission.

Instead, the document states generally that: "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." It also mentions "Software design and development, (including verification and validation testing, test and software quality procedures) was conducted using FDA's Guidance for the Content of Premarket Submissions for Software contained in medical devices, dated May 11 2005, as a guidance and per internal company requirements."

The modification in this 510(k) is the addition of the capability to set tidal volumes in volume-targeted modes down to 5 ml, compared to the previous lower limit of 10 ml.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details based on the provided text. The document confirms that testing was performed to demonstrate substantial equivalence, but it does not specify the quantitative acceptance criteria, the study design, or the results in the level of detail requested.

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This nebulizer compressor is an AC-powered air compressor nebulizer system intended to provide a source of compressed air for medical purposed for use in home health care. It is to be used with a pneumatic nebulizer to produce aerosol particles of medication for respiratory therapy for both children and adults.

This line-powered piston compressor is housed in a plastic cabinet (case). Dimensions are 7.5" (L) x 7.49" (W) x 4.18" (H) and weighs 3.3 lbs. It consists of a motor-driven piston compressor and a switch; it contains no consists of a noter electronic components. It operates from 115 VAC, 60 Hz. It is supplied with tubing, an instruction manual, and a Sidestream (510(k) cleared) nebulizer. The Inspiration Elite, Model HS456 is not be used without the nebulizer.

In use, the compressor is placed on a flat surface and the nebulizer tubing is connected to the hose barb. The unit is then turned on. Inlet air to the compressor passes through a replaceable filter.

The provided text describes a medical device submission (510(k)) for a nebulizer compressor but does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods for such a study.

The document is a summary of the 510(k) submission for the "Inspiration Elite Nebulizer Compressor with Nebulizer, Model HS456". It focuses on demonstrating substantial equivalence to a predicate device (InvaCare Envoy Jr., K# 992643) rather than proving performance against specific acceptance criteria through a clinical study.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Acceptance Criteria and Reported Device Performance: The document provides a "Functional Comparison Chart" (Section 8) comparing the subject device to the predicate device based on specifications like dimensions, weight, electrical requirements, average power consumption, and average flow rate. This chart does not present "acceptance criteria" in the sense of predefined thresholds for performance, but rather shows how the subject device's specifications align with those of the predicate.
• Study That Proves the Device Meets Acceptance Criteria: Section 9 explicitly states "Discussion of Clinical Tests Performed: Not Applicable." This indicates that no clinical study was performed to "prove the device meets acceptance criteria." Instead, the submission relies on non-clinical tests to demonstrate substantial equivalence.
• Sample size for the test set and data provenance: No test set is described as no clinical study was performed.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no clinical study with a ground truth was performed.
• Adjudication method for the test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
• Type of ground truth used: Not applicable.
• Sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance/equivalence:

1. A table of acceptance criteria and the reported device performance:
   The document includes a "Functional Comparison Chart" which outlines specifications for the subject device and its predicate. While not framed as "acceptance criteria," these are the performance characteristics presented for comparison:

   FUNCTION	INSPIRATION ELITE (Reported Performance)	ENVOY JR. (Predicate Performance)
   Model	HS456	1001RC
   Dimension	4.2" x 7.5" x 7.5"	4.1"x 7.0"x 7.0"
   Weight	3.3 lbs	3.5 lbs
   Electrical requirements	115VAC/60Hz	115VAC/60Hz
   Avg. Power consumption	89 -90 watts*	88 -89 watts*
   Avg. Flow Rate @ 10-15 psig	7.6 -6.8 Lpm*	7.6 -6.8 Lpm*
   Power Indication	No	No
   Intensity Control	No	No
   Intensity Indication	No	No
   Turn ON/OFF switch	Yes (switch)	Yes (switch)
   *Reference Exhibit #2 (Rietschle Thomas Compressor Comparison Data Table dated 8/10/04)

2. Study that proves the device meets the acceptance criteria:
   The submission explicitly states: "Discussion of Clinical Tests Performed: Not Applicable." The basis for demonstrating safety and effectiveness and substantial equivalence is non-clinical testing: "electrical, mechanical, environmental and EMC testing results outlined in the FDA DCRND November 1993 Draft 'Reviewer Guidance for Premarket Notification Submissions'."

The remaining points about sample sizes, data provenance, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment are not present in the provided text because no clinical or AI performance study, as typically understood in those contexts, was conducted or reported. The device's approval hinges on its substantial equivalence to a legally marketed predicate based on non-clinical performance characteristics and adherence to relevant standards and guidance documents.

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The Inspiration ™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System, with the addition of two new software options: 1) The Smart Positive Airway Pressure (SPAP) modification provides the Inspiration™ Ventilator System with a biphasic pressure mode that allows for spontaneous breathing at two separate PEEP baselines. 2) The Volume Targeted Ventilation (VTV) modification provides the Inspiration™ Ventilator System with a pressure based breath mode that targets tidal volume by adjusting the delivered pressure targets on a breath-to-breath basis. This modification includes Pressure Regulated Volume Control (PRVC) and Volume Support (VS). This option also includes Automode which allows patients the backup safety support of mandatory breaths if they stop breathing and transition back to their spontaneous mode when they are again breathing spontaneously. These modifications are implemented on the Inspiration™ Ventilator through additional functionality in software only. The existing modalities, pneumatic design, breath delivery control algorithms, electrical circuitry and user interface have remained unchanged from the cleared Inspiration™ ventilator device.

The provided text describes a 510(k) premarket notification for the eVent Medical Ltd. Inspiration™ Ventilator System with Smart Positive Airway Pressure (SPAP) and Volume Targeted Ventilation (VTV) options. This submission focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study outcome to prove achievement of those criteria in the format typically used for AI/ML device evaluations.

Therefore, many of the requested elements (like sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance metrics, and detailed ground truth establishment for training) are not explicitly present in the provided document, as it predates the common structured evaluation reporting for these types of technologies.

However, based on the information available, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria with specific performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) and corresponding device performance values. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices.

The "acceptance criteria" are implied to be that the new software modifications (SPAP and VTV) function similarly to the predicate devices' equivalent modes without introducing new questions of safety or effectiveness. The "reported device performance" is the conclusion that:

• The SPAP feature is "substantially equivalent to the BiVent mode on the Siemens Servoi ventilator (K022132)."
• The VTV modification (including PRVC and VS) is "substantially equivalent to PRVC and VS and on the Siemens Servoi Ventilator (K022132)."
• The Automode feature is "substantially equivalent to Automode on the Siemens Servoi Ventilator (K022132)."
• Overall, the device "meets its specifications and is safe and effective for its intended use."

This is a qualitative assessment of equivalence, not a quantitative performance measurement against predefined thresholds.

2. Sample Size Used for the Test Set and Data Provenance

Not explicitly stated. The document refers to "verification and validation testing" and "combined testing and analysis of results," but no specific sample sizes for a "test set" (in the context of AI/ML evaluation) are provided. The testing would have been conducted on the device itself, likely involving various simulated patient conditions and scenarios to verify correct functionality of the new software modes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this submission. The "ground truth" here is the expected mechanical and physiological response of the ventilator under various settings and patient conditions, and its equivalence to the predicate devices. This would typically be assessed by engineers, respiratory therapists, and physicians through functional testing, not by a panel of experts establishing a consensus ground truth for image interpretation or diagnosis as seen in AI/ML studies.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method, as the evaluation is not based on expert review of ambiguous cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is not an AI/ML clinical decision support device. It is a continuous ventilator with new software-driven ventilation modes. An MRMC study is not relevant to its evaluation.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is a standalone system with new software algorithms for ventilation control. Its performance was evaluated as such. There is no "human-in-the-loop" component in the sense of an AI assisting a human in a diagnostic task; the human (clinician) operates the device, and the device's algorithms control ventilation. The entire testing would, by definition, be "standalone" performance of the machine.

7. The Type of Ground Truth Used

The ground truth used for evaluating the ventilator's performance would be:

• Engineering specifications and expected physiological responses: The modes (SPAP, VTV) should control pressure and volume as designed and as observed in the predicate devices. This involves mechanical testing, simulations, and possibly animal or human subject testing (though not detailed here) to confirm that the delivered ventilation parameters (e.g., tidal volume, pressure) match the set parameters and physiological models within acceptable tolerances.
• Predicate device behavior: The "ground truth" for substantial equivalence is the established safe and effective performance of the predicate ventilators (Siemens - Elma AB. Servoi Ventilator with BiVent, K022132). The new device's modes are compared to the predicate's modes to ensure similar function.

8. The Sample Size for the Training Set

Not applicable. As a traditional medical device (ventilator) with software modifications, there is no "training set" in the context of machine learning. The software was developed and validated, but not "trained" on a dataset like an AI algorithm would be.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the AI/ML sense. The "ground truth" for the software development would be the engineering requirements, clinical specifications, and intended functionality derived from established medical knowledge and predicate device capabilities.

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The InspirationTM Ventilator System is indicated for use with a wide range of patients from infant through adult, requiring respiratory support for a wide range of clinical conditions in hospital, hospital-type facilities and intra-hospital transport.

The Inspiration™ Ventilator System is housed in a metallic enclosure, comprising clear anodized aluminum with painted finish and is mounted on a mobile stand. User controls and display screen are located on the front face of the Ventilator. Display and controls operation is described in the Ventilator Settings and Controls section of the User Manual (See Section 14 of this Submission). Ventilation parameters are programmed by the operator, using the function and navigation keys plus the Push & Turn control device on the Ventilator front panel, in conjunction with selectable display screens. The programmed data from the User Interface is processed by the main microprocessor and stored in ventilator non-volatile memory. The microprocessor uses the stored data in the control of breath delivery. Oxygen and air supply connections are located on the back of the Ventilator. The patient breathing circuit connection is located below the front face of the unit, together with a pneumatic outlet for driving an optional accessory jet nebulizer. The Ventilator stand serves to support the main Ventilator unit, breathing circuit tubing and accessory equipment, facilitating connection to the Ventilator. The Inspirations Ventilator System incorporates three communications interfaces, namely, a Nurse Call interface, an RS-232 and an Ethernet interface. The Nurse Call interface comprises normally open and normally closed relay contacts (changeover switch) acting simultaneously with an alarm condition. Both the RS232 and Ethernet interfaces enable the same data transmission to receiving terminals such as nurse and physician workstations and PC equipment. The Inspiration ... Ventilator System consists of two major systems, the pneumatic system and the electrical/electronic system, which combine under software control to deliver respiratory support at operator-determined parameters. The pneumatic system, under microprocessor control, supplies air and oxygen to the patient system, external to the device. The electricallelectronic system inputs and supervises one of three alternative power sources to the unit and provides electronic control of the ventilator's pneumatic system components. The Inspiration™ Ventilator System can operate with a range of standard ventilator accessories, such as breathing circuits, nebulizer and humidifier.

I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves the device meets acceptance criteria, or any of the detailed study parameters you've requested.

The document is a 510(k) summary for the "Inspiration™ Ventilator System" from eVent Medical Ltd. It covers:

• Company Information: Manufacturer, contact person.
• Device Name: Proprietary, common, and classification.
• Equivalent Devices: Predicate devices used for substantial equivalence comparison.
• Device Description: Physical layout, user interface, communication interfaces.
• Intended Use: Broad patient range (infant to adult), clinical conditions, environment of use (hospital, intra-hospital transport).
• Technological Characteristics: How it provides ventilation (pressure/volume-based), power sources, integral compressor, available ventilation modes.
• Certification Statement: Affirmation of truthfulness and accuracy of submitted data.
• FDA Clearance Letter: Official letter from the FDA stating substantial equivalence and allowing marketing.
• Indications for Use Statement: Formal statement of the device's intended use.

This document focuses on regulatory clearance based on substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and results. Such detailed study information would typically be found in a separate section of a 510(k) submission, often within performance testing reports, which are not included in this summary.

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